DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosures of the prior-filed applications, Application No.’s 62154599, 62217542, 62301546, 15141655, 15334053, 62412657, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The above listed prior applications fail to disclose the substantially sinusoidal configuration of the at least one elongate curved structural member (claim 1). Therefore, claims 1-7 receive a priority date of 10/23/2017, which is the filing date of application No. 15/791,279.
The disclosures of the prior-filed applications, Application No.’s 62154599, 62217542, 62301546, 15141655, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The above listed prior applications fail to disclose a second support beam, as required by claim 8. Therefore, claims 8-14 receive a priority date of 10/25/2016, which is the filing date of application No. 15334053.
The disclosures of the prior-filed applications, Application No.’s 62154599, 62217542, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The above listed prior applications fail to disclose a support beam, as required by claim 18. Therefore, claim 18 receives a priority date of 3/14/2016, which is the filing date of application No. 62301546.
The disclosure of the prior-filed application, Application No. 62154599, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The above listed prior application fails to disclose the leading edge portion including a substantially smooth surface and the trailing edge portion including a monolithic structure including at least one receptacle, as required by claims 15, 16, 17, 19, and 20. Therefore, claims 15, 16, 17, 19, and 20 receive a priority date of 9/11/2015, which is the filing date of application No. 62217542.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation “including a first spiral member and a second spiral member” in lines 21-22. However, a first spiral member is already recited in line 16 and a second spiral member is already recited in lines 19-20. It is unclear whether the limitation is requiring the second plurality of coils to include a first spiral member and a second spiral member (in addition to those spiral members already recited), or whether the limitation was inadvertently included. Please clarify.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kloss (Pub. No. US 2013/0116793 A1).
Regarding claims 1-4, 6, and 7, Kloss discloses an implant (figures 3A-3C), comprising: a body having a leading edge portion, a trailing edge portion, and an intermediate portion extending between the leading edge portion and the trailing edge portion; wherein the leading edge portion includes a substantially smooth surface forming a substantial majority of a leading edge surface of the leading edge portion; wherein the trailing edge portion includes a monolithic structure including at least one receptacle configured to receive an insertion tool (all features illustrated in figures 3a and 3b); wherein the intermediate portion includes a plurality of elongate curved structural members continuously formed with at least one of the leading edge portion and the trailing edge portion (illustrated in figures 3a and 3b; paragraph 0047 discloses that the shapes are curved); wherein the elongate curved structural members are configured such that the intermediate portion remains substantially rigid under compressive forces during insertion of the leading edge portion between bone surfaces of a patient (figures 3a and 3b; paragraphs 0099 and 0104); and wherein the elongate curved structural members include at least one elongate curved structural member extending longitudinally from the leading edge portion to the trailing edge portion of the implant and having a substantially sinusoidal configuration (figures 3a and 3b, in the case wherein the tubular structures are curved/round as disclosed in paragraph 0047, the members have a sinusoidal curve). The leading edge portion and the trailing edge portion extend in a first plane; and wherein the sinusoidal configuration oscillates in a second plane that is substantially perpendicular to the first plane (illustrated in figure 4). The sinusoidal configuration includes crests and valleys; and wherein the at least one elongate curved structural member has a plurality of flattened bone contacting regions at the crests of the sinusoidal configuration (the top and bottom surfaces of the curved member are flattened and configured for contacting the endplates of the vertebra, figures 3a, 3b, and 4). The at least one elongate curved structural member has a plurality of flattened bone contacting regions at the valleys of the sinusoidal configuration (the top and bottom surfaces of the curved member are flattened and configured for contacting the endplates of the vertebra, figures 3a, 3b, and 4). The body is substantially wedge- shaped (figure 4). The implant is configured for implantation in the sacroiliac joint (figure 4, the implant is configured to be placed in the SI joint if one so desires, so it meets the claimed limitation).
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Claim(s) 8-11, 13, and 14 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Schneider et al. (Pub. No. US 2016/0081809 A1).
Regarding claims 8-11, 13, and 14, Schneider et al. disclose an implant 10 (figure 7A), comprising: a body 12 having a leading edge portion 16, a trailing edge portion 18, and an intermediate portion extending between the leading edge portion and the trailing edge portion (figure 7A); wherein the leading edge portion includes a substantially smooth surface forming a substantial majority of a leading edge surface of the leading edge portion (figure 7A); wherein the trailing edge portion 18 includes a monolithic structure 24 including at least one receptacle 26 configured to receive an insertion tool (paragraph 0070); wherein the intermediate portion includes a plurality of elongate curved structural members 20 (paragraph 0075 discloses that the structural members “struts” are curvilinear or circular in cross-section) continuously formed with at least one of the leading edge portion and the trailing edge portion (figure 7A; paragraphs 0077, 0078); wherein the elongate curved structural members 20 are configured such that the intermediate portion remains substantially rigid under compressive forces during insertion of the leading edge portion between bone surfaces of a patient (paragraph 0061); wherein the intermediate portion includes a first support beam 14 extending between the leading edge portion 16 and the trailing edge portion 18; wherein the intermediate portion includes a second support beam 14 extending between the leading edge portion 16 and the trailing edge portion 18 and substantially parallel to the first support beam 14 (figure 7A); and wherein at least one of the elongate curved structural members 20 bridges across a gap between the first support beam 14 and the second support beam 14 (figure 7A). A plurality of the elongate curved structural members 20 bridge across the gap between the first support beam 14 and the second support beam 14; and wherein the plurality of elongate curved structural members 20 bridging across the gap are substantially parallel to one another (illustrated in figure 7A). The implant further including a third support beam 14 extending between the leading edge portion 16 and the trailing edge portion 18 and substantially parallel to the first support beam 14 and the second support beam 14 (figure 7A). The plurality of elongate curved structural members 20 includes at least two members 20 attached to the first support beam 14 and respectively extending to the second support beam 14 and the third support beam 14 in a V-like configuration (figure 7A). The body 12 is substantially wedge- shaped (the body is wedge shaped along its lateral axis, figure 7A). The implant is configured for implantation in a sacroiliac joint (paragraph 0011).
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Claim(s) 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koo et al. (Pat. No. US 6,428,575).
Regarding claims 15-20, Koo et al. discloses an implant 1 (figures 3 and 4), comprising: a body having a leading edge portion, a trailing edge portion, and an intermediate portion extending between the leading edge portion and the trailing edge portion (illustrated in figures 3 and 4); wherein the leading edge portion includes a substantially smooth surface forming a substantial majority of a leading edge surface of the leading edge portion (figure 4); wherein the trailing edge portion includes a monolithic structure including at least one receptacle 40 configured to receive an insertion tool (figure 4); wherein the intermediate portion includes a plurality of elongate curved structural members 11, 12 continuously formed with at least one of the leading edge portion and the trailing edge portion (figures 3 and 4); wherein the elongate curved structural members 11, 12 are configured such that the intermediate portion remains substantially rigid under compressive forces during insertion of the leading edge portion between bone surfaces of a patient (figures 3 and 4; col. 3, lines 20-30); the plurality of elongate curved structural members 11, 12 including a first spiral member 11 extending from the leading edge portion to the trailing edge portion and including a first plurality of coils; and the plurality of elongate curved structural members including a second spiral member 12 extending from the leading edge portion to the trailing edge portion and including a second plurality of coils (figures 3 and 4), including a first spiral member and a second spiral member; wherein the first plurality of coils are interlaced in alternating fashion with the second plurality of coils (figures 3 and 4). The first plurality of coils and the second plurality of coils are formed by substantially helical members (figures 3 and 4). At least one of the first spiral member 11 and the second spiral member 12 is a bone contacting member configured to contact at least one surface of the patient's bone upon insertion of the implant between the bone surfaces (figures 3 and 4). The implant further including at least one support beam (illustrated in figure 4) extending between the leading edge portion and the trailing edge portion. The body is substantially wedge- shaped (figure 4). The implant is configured for implantation in the sacroiliac joint (figure 4, the implant is configured to be placed in the SI joint if one so desires, so it meets the claimed limitation).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kloss (Pub. No. US 2013/0116793 A1) in view of Kohrs et al. (Pat. No. US 5609636).
Regarding claim 5, Kloss discloses the claimed invention except wherein the receptacle includes female threading configured to receive male threading on an insertion tool.
Kohrs et al. teaches that a receptacle 503 for receiving an insertion tool comprises female threading 504 in order to securely mate the insertion tool with the implant (col. 11, lines 3-9; figure 22).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the receptacle disclosed by Kloss to have a female threading as taught by Kohrs et al., and to modify the insertion tool to have male threading, in order to securely mate the insertion tool with the implant (col. 11, lines 3-9).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider et al. (Pub. No. US 2016/0081809 A1) in view of Kohrs et al. (Pat. No. US 5609636).
Regarding claim 12, Schneider discloses the claimed invention except wherein the receptacle includes female threading configured to receive male threading on an insertion tool.
Kohrs et al. teaches that a receptacle 503 for receiving an insertion tool comprises female threading 504 in order to securely mate the insertion tool with the implant (col. 11, lines 3-9; figure 22).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the receptacle disclosed by Kloss to have a female threading as taught by Kohrs et al., in order to enable the implant to be securely mated to an insertion tool (col. 11, lines 3-9).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11819419 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus more specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO form 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynnsy Summitt whose telephone number is (571)270-7856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773